None listed
Conditions
Brief summary
The aim of this study is to evaluate the impact of Smart-HF (a mHealth platform) on reducing readmission to hospital and other secondary outcomes. The Smart-HF platform is an app for the patient that delivers educational information, goal-setting, homework tasks, self-monitoring and questionnaires to patients with heart failure, and allows patient progress and outcomes to be measured via a clinician portal. Participants are patients admitted to the general or cardiology wards with Acute Decompensated Heart Failure (ADHF). Enrolled patients classified with a high risk of hospital readmission and/or death - i.e., equal to or greater than median of predicted risk, 33% based on the TAS-Help study algorithm developed by CIs Marwick and Huynh - will be randomised to either usual care or Smart-HF plus usual care, with stratification by study site and type of HF (reduced or preserved ejection fraction). The primary endpoint is quality of life at 90 days post hospital discharge. Secondary endpoints - 30-day readmission, 30- and 90-day composite outcome.
Interventions
We will conduct a two parallel-arm, type 2 hybrid randomised controlled trial to evaluate the impact of Smart-HF on quality of life and other secondary outcomes including reducing readmission to hospital. Enrolled patients classified with a high risk of hospital readmission and/or death - i.e., equal to or greater than the median of predicted risk, 33% based on the TAS-Help study algorithm developed by CIs Marwick and Huynh - will be randomised to either usual care or Smart-HF plus usual care, w
We will conduct a two parallel-arm, type 2 hybrid randomised controlled trial to evaluate the impact of Smart-HF on quality of life and other secondary outcomes including reducing readmission to hospital. Enrolled patients classified with a high risk of hospital readmission and/or death - i.e., equal to or greater than the median of predicted risk, 33% based on the TAS-Help study algorithm developed by CIs Marwick and Huynh - will be randomised to either usual care or Smart-HF plus usual care, with stratification by study site and type of HF (reduced or preserved ejection fraction). The intervention arm (SMART-HF) will involve the application of the Smart-HF app. Smart-HF provides patients a home-based heart failure care program which is linked to a clinician portal for creation of care plans and surveillance. The clinician-created care plan will identify goals for behaviour change such as increasing physical activity, as well as observations of symptoms of heart failure, such as rapid weight gain. Symptom observations are to be input into the Smart-HF app daily and based on this intensified home surveillance, the site co-ordinator (Heart Failure nurse) may arrange review of the patient at the rapid access clinic. Other patient reported outcome measures, including the Kansas City Cardiomyopathy Questionnaire are required at 30- and 90-days and 12 months. Smart HF also includes access to educational content on heart failure (self-)management. The linked clinician portal will be used to assess or monitor adherence or fidelity to the intervention. The Smart-HF software, supported by smartphones or tablets, IOS and android software, delivers educational information, goal-settings, homework tasks, self-monitoring and questionnaires for heart failure, to allow patient progress and outcomes to be measured. Primary endpoint is quality of life at 30 days. Secondary outcomes include hospital readmission at 30 and 90 days post hospital discharge and 90-day composite outcome of days alive and out of hospital.
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Be eligible for Medicare Emergency Department admission with a primary diagnosis of Acute Decompensated Heart Failure confirmed by the treating physicians, in accordance with the HF guidelines. TasHelp risk score >33 Ownership or use of a smartphone or tablet device able to meet Cardihab app requirements (Android OS 9 or later / Apple iPhone or iPad iOS 13 or later).
Exclusion criteria
Unable to provide written informed consent to participate in this study. Low e-health literacy score (eHEALS <26) or lack of access to a smartphone/tablet or wi-fi network Patients that need palliative care. Participating in another clinical research trial where randomisation to study arms would be unacceptable. Patients who live in an aged care facility (e.g., Nursing Home) Moderate to severe primary mitral or aortic valve disease Concomitant unstable angina, acute myocardial infarction Cardiac device malfunction Endocarditis Patients with Left Ventricular Assistant Device (LVAD) Patients with asymptomatic Left Ventricular (LV) dysfunction Potentially reversible LV dysfunction, such as post-partum, alcoholic cardiomyopathy, hyperthyroidism. Abuse of alcohol or drugs Concomitant terminal non-cardiac illnesses that could influence 12-month prognosis (e.g. advanced malignancy) Inability to acquire interpretable images (identified from baseline echo) In the investigators opinion any other condition that may affect the safety procedures of the study. (Patient and personnel)
Outcome results
None listed